The noble Baroness, Lady Thornton, got to the heart of this when she said that these discussions are central to our debate on the Bill and its purpose.
I preface my comments on the amendments by drawing on my experience as a Minister with responsibility for preparing the health and social care sector for Brexit and for medicine regulation. During that time, I spent hours and hours—days and days—of time with pharma and medical device companies, patients and others. There was a consistent message from almost all of them about the desirability of remaining part of the EU family if possible and the importance of the MHRA and our notified bodies as regulators within that regime. I, together with others, worked extremely hard to make sure that that was recognised in the withdrawal agreement that was agreed at the time. We managed to create a special category of safety products. For those who remember back two or three years, there were chemicals, pharmaceuticals and medical devices in the withdrawal agreement and, indeed, the political declaration. I worked very hard to achieve that position and supported it.
It might also be worth reminding noble Lords that Parliament passed up the opportunity to agree that withdrawal agreement. It did not succeed. That has led to a different Government with a different agenda and with a majority, which might be something for us all to reflect on.
I make those points only so that noble Lords will understand that my concerns with the amendments on aligning with the EMA and European regulation in general are not ideological but practical. Actually, this is a very heterogenous group of amendments: it ranges from alignment through to collaboration to similarity where possible. When considering the issues around this, we need to tread very carefully as to what we commit ourselves to. The fact is that, as negotiations have progressed, it has become completely clear that the European Commission will not tolerate any meaningful associate membership: you are either in or you are out, and there is no possibility of the UK participating in making the rules that bind it. Clearly, being in is not compatible with leaving the European Union, so the question that falls to us is what we do when we are out. What should we do as a sovereign regulator that is not part of the EMA?
This is where I disagree with those amendments that seek to align us with the EMA. The truth is that we cannot have the best of both worlds; we cannot—as
the Prime Minister might put it—have our cake and eat it. We cannot be in and take advantage of the opportunities that being out gives us. Tying ourselves in advance and in perpetuity to EU regulation over which we have no control or, critically, judgment of quality, would be a big mistake.
It is quite right that we should seek to mitigate the negative impacts of leaving the EMA family. I have never sought to sugar-coat those—I do not take a Panglossian view of the consequences—but tying ourselves in such a way is not the way to do it. Multiple stringent regulators in the world do just as good a job, if not better, as our MHRA—in Japan, Switzerland, Canada, Singapore and bits of the EFTA. We should as a nation be seeking to accept licensing applications and modelling our regulatory structures on all and any of those that we think are the best. That is the way to take advantage of our freedoms and give us the best possible opportunity of getting innovative medicines and products as they come on to market in any market in the world.
We do not need, as the noble Lord, Lord Hunt, and others, said, to create our own bespoke, novel, difficult regulatory system that puts up more barriers to innovation; nor should we tie ourselves to one other regulatory regime. I use just one example to exemplify why I think that is true. It is a well-worn example but is worth rehearsing: the introduction of the HPV vaccine. That was something that most regulators in the EMA family did not want to proceed with. The MHRA provided a very compelling case for us to do so. European countries did so. The effect of that in England alone has been to reduce HPV infections among 16 to 21 year-old women—the figures are a couple of years out of date but are probably still accurate—by 86%. Bear in mind that HPV causes 80% of cervical cancers among women. We might be tying ourselves to things that we regret and which cause harm; I know that that is not something that anyone would want to do.
I note from the ABPI’s briefing—obviously, I have worked closely with it—that it does not call for alignment with the EMA. It calls for making sure that
“the information or data required by the EU regulator is consistent with other leading regulators around the world and benchmarked against them for speed and approval.”
It also calls for the UK to apply for full membership of the ICH, as the amendment in the name of the noble Baroness, Lady Jolly, calls for—I quite agree with that—and generally to look to provide leadership on developing global regulatory standards in human medicines.
I utterly understand the impulse. The Government have partly got themselves into this difficult situation by creating a vacuum into which people are seeking to put policy. That is completely understandable but it would be a mistake to tie ourselves to one particular regulator. It may not be quite as true of clinical trials—I defer to the expertise of others—although I note that the ABPI briefing paper does not talk about the clinical trials directive; instead, it uses a much broader palette and says that future clinical trials and regulations in the UK should both support and enable international collaboration.
I know that that is not the only position and that people take a different view, but as we move forward, we will want to tread carefully over which regulators we seek to collaborate with, emulate and draw on, rather than tying ourselves to an in-perpetuity relationship that we may come to regret on occasion.